Novartis CEO: Leqvio, Pluvicto off to solid starts, but blockbuster sales will take time

Novartis has high hopes for newly launched heart drug Leqvio and cancer therapy Pluvicto. To hear CEO Vas Narasimhan tell it, both products are off to a strong start in their multiyear journeys to more than $2 billion in sales each.

With many countries still working through Leqvio reimbursement dynamics, the PCSK9-targeted drug collected $14 million sales in the first quarter compared with $1 million a year ago. The drug nabbed its EU nod in December 2020 and secured its U.S. go-ahead a year later.

“The leading indicators point to the foundations being put in place” for Leqvio to become a “very significant brand” for Novartis, Narasimhan said during an investor call Tuesday.

Novartis’ commercial team has so far reached more than 90% of targeted doctors, the CEO said. For Leqvio’s launch, Novartis is taking a population health-based approach at 200 large U.S. healthcare systems in an effort to identify eligible patients. Among them, at least 50 systems have now ordered Leqvio, Narasimhan said.

The company is working to drive “more depth” with those accounts, potentially reaching more patients. To help with reimbursement talks, Leqvio has received a permanent J-code as an injection administered by a healthcare professional.

Leqvio is going up against injectable PCSK9 drugs, namely Amgen’s Repatha and Sanofi and Regeneron’s Praluent, and oral PCSK9 candidates have started to report clinical data. But with a global population of 60 million eligible patients, Narasimhan said there’s plenty of room for multiple agents in the class.

“Our goal is to grow the market, bringing forward a twice-a-year [Medicare] Part B medicine,” Narasimhan said. He argued that Leqvio’s twice-a-year dosing offers a unique value proposition versus other frequently administered drugs, which patients typically don’t comply with especially for asymptomatic disease.

Despite the big market opportunity, the chief executive still cautioned that, like other meds in cardiovascular disease, it will be a “long journey” for Leqvio to reach its full potential.

Meanwhile, freshly FDA-approved radioligand therapy Pluvicto could be another medicine that reaches $2 billion in sales—but that will take time.

After snagging an FDA green light for late-line treatment of PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), Novartis has secured agreements to have its companion radioactive diagnostic agent distributed widely among diagnostic centers, Narasimhan said on the call. The company hopes to remove any constraints on imaging and diagnosing patients over the coming months.

With Pluvicto, Novartis is building on the experience with its first radiopharmaceutical Lutathera, initially targeting about 250 specialized radioligand therapy treatment centers already in Lutathera’s network. Over 40 centers have already joined Pluvicto’s ordering system.

But as Narasimhan noted, late-line prostate cancer only represents around $500 million to $750 million of market potential for Pluvicto. The bigger opportunity lies in earlier lines of treatment.

There, Novartis expects a readout in the second half of this year from a phase 3 clinical trial of Pluvicto in chemo-naïve patients with mCRPC who were previously treated with an androgen-receptor-directed therapy. Another study is testing the drug in hormone-sensitive disease. If successful, they could potentially expand Pluvicto’s patient population by three to four times, Narasimhan noted.

For those potential expansions, Novartis plans to expand its radioligand therapy network to about 550 centers in what Narasimhan called a “multiyear effort.”

Leqvio and Pluvicto are key assets in Novartis’ portfolio to drive near- and mid-term growth. In the first quarter, the Swiss pharma saw sales grow 5% at constant currencies to $12.5 billion, with heart combo drug Entresto and multiple sclerosis therapy Kesimpta being the star performers. For 2022, Novartis still expects full-year sales to grow at mid-single digit percentages.